The following data is part of a premarket notification filed by Hemodynamics, Inc. with the FDA for Leunomed Rfb 5000.
| Device ID | K881164 |
| 510k Number | K881164 |
| Device Name: | LEUNOMED RFB 5000 |
| Classification | Device, Biofeedback |
| Applicant | HEMODYNAMICS, INC. 5301 NORTH FEDERAL HGWY. STE. 140 Boca Raton, FL 33431 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz HEMODYNAMICS, INC. 5301 NORTH FEDERAL HGWY. STE. 140 Boca Raton, FL 33431 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1989-04-24 |